FDA-Device2020-11-04Class II
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
GE Healthcare, LLC
Hazard
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Affected count
64 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2021Don't want to check this manually?
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